India’s Drug Crossroads

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On Monday the pharmaceutical company Novartis will bring an action against the Indian government in the High Court in Chennai, claiming that it should have been granted a patent for its drug Glivec.

The company will argue that Section 3d of the Indian Patent Act of 2005, under which it was refused the patent, is unconstitutional because the Indian government had agreed to abide by a World Trade Organization patent agreement. Novartis wants the section of the law repealed and its patent approved.

If you were to believe the international medical journals and press, you would think that an American-backed pharmaceutical company is leading an assault on India designed to prevent the poorest from receiving life-saving drugs. The Lancet, a respected medical journal, recently editorialized in favor of a campaign “defending the legal rights of the world’s poorest people to access the essential medicines they need.” The journal lauded the campaigners who are “calling for the rules of Trade Related Aspects of Intellectual Property … a binding World Trade Organisation agreement, to be upheld and are targeting the pharmaceutical industry and the US Government.”

As the Lancet views it, “Novartis is taking the Indian Government to court over its decision last year not to grant a patent for the cancer drug. … The patent was rejected under … legislation that India implemented 2 years ago. Section 3 (d) stipulates that patents should only be granted on medicines that are truly new and innovative but Novartis is challenging this rule.”

The reality is far more complex.

Actually, Indian protectionist interests have prevented global competition and innovation in its pharmaceutical sector by encouraging amendments to Indian patent law. Their efforts are short-sighted and unfair both to Indian scientists who are more than capable of competing globally, and to Indian consumers who will not receive the best drugs under the current law.

In 1995 India signed on to the World Trade Organization’s agreement and was given until January 2005 for product patents to be in place. With the new Indian patent law of 2005, protection for innovation seemed assured, but after lobbying from local producers, amendments were made to the law. These are unique to India and in my opinion illegal under the WTO agreement.

One key amendment, Section 3(d), creates additional hurdles for pharmaceutical patents by deeming that derivatives of known substances are not considered patentable unless they can be shown to differ in terms of efficacy. One has to demonstrate more than the usual “novelty, commercial applicability and non-obviousness” criteria under the WTO agreement. Applying only to drug development, this amendment violates the WTO agreement because the agreement disallows WTO member states from rendering it more difficult to obtain a patent in one technical field over another.

Most physicians and patients would agree that the Novartis drug represents an innovative anti-cancer breakthrough and deserves a patent. In 1983, Novartis scientist Dr. Alex Matter led the charge for a new drug that would target only cancer cells. As greater genomic knowledge became available, Novartis scientists ultimately were successful, resulting in Glivec. First patented in 1994 in Taiwan and then in 1996 in America, Glivec was first used on leukemia patients in 2001.

Novartis continued to work on the drug, developing another, beta crystal, version. That is the one for which it applied for a patent in India. Ironically, had India had patent laws when Novartis first started filing globally, the company probably would have received a patent. For the Indian government denied Novartis a patent under Section 3(d), claiming that the second version was not sufficiently distinct from the first.

Arguably, even under Indian law today, Novartis could qualify for a patent. The beta version performs better in some tests, implying that it is a clinical improvement over the older version, just what Section 3(d) demands.

Far from Novartis keeping the poor from receiving needed drugs, it is India’s patent law that limits India’s drug market. India’s patent hurdles discourage drug companies from operating there, discourage innovation, for many drugs are developed from existing substances, and discourage drug companies from working on diseases that may be unique to India.

This case is one of principle. It will not affect Indian patients, for Novartis distributes the drug free to most of those who need it. But if Novartis loses the case, it will send a signal to drug companies that India is not welcoming.

Novartis officials told me that they didn’t want to go to the Indian High Court, but it was the only course remaining, for only countries can demand arbitration at the World Trade Organization and no country has complained.

India is at a crossroads. It can follow the route it has taken in software engineering, with sensible intellectual property protection that spurs growth, or it can travel the opposite route with idiosyncratic rules that limit growth and innovation.

Mr. Bate is a resident fellow of the American Enterprise Institute.


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